ACI's 40th FDA Boot Camp - WEB

EARN CLE/ETHICS CREDITS

American Conference Institute’s 40 th

March 22–23, 2023 (EST)

Virtual Conference

Training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts

Join us for Pre and Post Conference Workshops: Pre-Conference Workshop A (with 1 hour Ethics Bonus) FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws Pre-Conference Workshop B Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations Post-Conference Workshop C Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

Distinguished Conference Chairs: Stacy Cline Amin Partner Morrison Foerster Former Chief Counsel, FDA

Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C.

Preeminent members of the nation’s Food and Drug bar will drill you on the essentials of FDA law and regulation and help you: ĉ COMPREHEND the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR ĉ MASTER the basics of the application and approval processes for drugs and biologics ĉ APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products ĉ GAIN a practical working knowledge of clinical trial process for pharmaceutical products ĉ RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process ĉ DECIPHER the requirements for the advertising, marketing, and promotion of drugs and biologics ĉ UNDERSTAND the importance of cGMPs to the post-approval regulatory process

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Through nearly 20 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Don’t miss your opportunity to join their ranks.

T

he approval process…pre-approval concerns…product labeling…clinical trials… adverse events reports…patent concerns…and exclusivity—these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. Recent news stories and high-profile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts.

For this reason, ACI’s FDA Boot Camp returns for its 40th iteration—in a fully virtual format—with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real-world examples that will help them to excel in their everyday practices.

A distinguished faculty of top FDA regulatory authorities—a “Who’s Who of the FDA Bar” —will share their knowledge and provide you with critical insights on: ç The organization, jurisdiction, functions, and operations of FDA ç The essentials of the approval process for drugs and biologics ç The role of the Hatch-Waxman Act in the patenting of drugs and biologics ç Clinical trials for drugs and biologics ç Labeling in the drug and biologics approval process ç cGMPs and other manufacturing concerns relative to products liability ç Proactive adverse events monitoring and signal detection ç Recalls, product withdrawals, and FDA oversight authority

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DISTINGUISHED CO-CHAIRS Stacy Cline Amin Partner Morrison Foerster (Washington, DC) Former Chief Counsel, FDA

Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

DISTINGUISHED SPEAKER FACULTY Jennifer L. Bragg Partner Skadden LLP (Washington, DC)

Chad Landmon Partner and Chair of Intellectual Property and FDA Practice Groups Axinn, Veltrop & Harkrider LLP

Cathy L. Burgess Partner Alston & Bird LLP (Washington, DC)

Seth Mailhot Partner Husch Blackwell

Torrey Cope FDA Regulatory Partner Sidley Austin LLP (Washington, DC) Delia A. Deschaine Member of the Firm (Partner) Epstein Becker & Green (Washington, DC) Kyle Y. Faget Partner, Co-Chair, Health Care Practice Group Foley & Lardner LLP (Boston, MA) Li Feng, Ph.D. Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC) Bryant M. Godfrey Partner and Co-Chair, Healthcare & Life Sciences and FDA Practice Groups Foley Hoag LLP Matt Hegreness Partner (FDA Regulatory) Covington & Burling LLP (Washington, DC)

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Christopher M. Mikson, MD, JD Partner DLA Piper Joshua M. Oyster Partner Ropes & Gray LLP (Washington, DC) Kinsey S. Reagan Partner Kleinfeld, Kaplan & Becker LLP Alexander J. Varond FDA Partner and FDA Litigation Co-Chair, Technology & Life Goodwin (San Francisco, CA) Jason G. Winchester Partner Jones Day (Chicago, IL) Benjamin Zegarelli Of Counsel Mintz (New York, NY)

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Pre-Conference Workshops Tuesday, March 21st, 2023 (EST)

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Pre-Conference Workshop A

Clock

9:00 AM–12:00 PM (10:30–11:00 AM Break)

EARN 1 ETHICS BONUS CREDIT

FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws microphone-alt Christopher M. Mikson, Partner, DLA Piper LLP (Washington, DC) This workshop provides a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of FDA and obtain a basic understanding of the pre-approval, approval, and post-approval processes. This session also provides a built-in hour of ethics credit.

Topics of discussion will include: • Examining the FDA’s structure, authority, and organization

• Exploring the clinical trials process

• The 3 major FDA centers and their roles

• Evaluating post-market dilemmas and enforcement

» CDER (Drug) » CBER (Biologics) » CDRH (Device) • Reviewing major FDA regulations and applicable laws • Defining drugs, biologics, and devices • Understanding the role of labeling with respect to these definitions • Differentiating types of drug applications (INDs, NDAs, and ANDAs)

• Investigating biological products and biosimilars • Understanding recalls and withdrawals • Examining recent developments at FDA • FDA’s policies and procedures • Administrative Procedures Act • Working with the FDA through formal and informal dispute resolution mechanisms • Analyzing ethical dilemmas that may occur throughout various stages of interaction with the FDA, including the approval process related to the disclosure of adverse information

12:00–1:30 PM Lunch Break

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Pre-Conference Workshop B

Clock

1:30–4:30 PM (2:30–3:00 PM Break)

Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations microphone-alt Kyle Y. Faget, Partner, Co-Chair, Health Care Practice Group, Foley & Lardner LLP (Boston, MA) Joshua M. Oyster ,, Partner, Ropes & Gray LLP (Washington, DC) This workshop will provide an introduction and in-depth overview of medical devices, combination products, and companion diagnostics as well as the FDA regulations which govern these products. Topics of discussion will include:

Medical Devices • Reviewing the history of FDA device regulations

• Determining premarket approvals

• Examining the basics of device classification and the FDA’s review process

• Exploring the 510(k)-clearance process

• Analyzing the clinical trials process for medical devices

• Discussing key regulatory requirements, information, and concepts

• Assessing strategies to obtain clinical data

Combination Products • Defining the requirements for combination product classification and approval • Selecting the proper regulatory pathway • Exploring the Request for designation (RFD) process and the newly created pre-RFD process

• Determining the role of the Combination Product Policy Council and agencies regulating combination products • Examining existing cGMP’s for combination products

Companion Diagnostics • Exploring the regulations of laboratory developed tests (LDTs) • Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs • Utilizing companion diagnostics via smart technologies

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Main Conference Day 1 Wednesday, March 22 , 2023 (EST) nd

8:15

Co-Chairs’ Opening Remarks microphone-alt Stacy Cline Amin, Partner, Morrison Foerster (Washington, DC),

OTC Products • Understanding the concept of “OTC” (OTC-ness) • Examining the OTC Review and monographs » Differences between approved and monographed OTC drug products • Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements

Former Chief Counsel, FDA

10:15

Kurt R. Karst, Partner, Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

10:45

8:30

Exploring New FDA Initiatives microphone-alt Stacy Cline Amin, Partner, Morrison Foerster (Washington, DC), Former Chief Council, FDA

Kurt R. Karst ,, Partner, Hyman, Phelps & McNamara, P.C. (Washington, D.C.) This panel will discuss how the Agency—now under the leadership of Dr. Califf will move forward with new initiatives including an evolving response to COVID-19 and examine key priorities.

The Pre-Approval and Approval Process

Exploring FDA's Expedited Programs: Applicability and Eligibility microphone-alt Matt Hegreness, Partner (FDA Regulatory), Covington & Burling LLP (Washington, DC)

• Distinguishing among the different FDA programs for expedited review, authorization and approval of drug products • Evaluating the criteria for eligibility, benefits, and limitations of each program • Understanding accelerated approval, surrogate, and intermediate clinical endpoints • Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs • Reviewing priority review • Factoring expedited programs into your drug development strategy

9:15

11:45

Navigating the Approval Process for Drugs and Biologics microphone-alt Kinsey S. Reagan, Partner, Kleinfeld, Kaplan and Becker LLP (Washington, DC)

Innovator Products: New Drug Applications and Biologic License Applications The Drug Review Process • Reviewing the fundamentals of applications; from submission, through filing and beyond • Making sense of PDUFA Goals, fast track, break through status, and other process enhancements • Use of administrative appeals

Rx Drugs (Small Molecules) • Understanding the difference between “new drugs” and other drugs • Examining the research, development, and approval process for new drugs • Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)

Biological Products (Large Molecules) • What are biological products in relation to traditional drugs?

• Deciphering the biologics license application (BLA) • How do the research, development, and approval process for biological products differ from the process for new drugs?

• Exploring key similarities and differences between the drug and biological product schemes

NDAs and BLAs • Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs • Identifying applications for fixed-dose combination drugs • Distinguishing complex molecules regulated through NDAs from small molecules • Examining standards for approvals • REMS

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Morning Break

1:1 Networking Break 12:00

Lunch Break

12:45

Appreciating the Nuances of the Approval Process for Controlled Substances microphone-alt Delia Deschaine, Epstein, Becker & Green (Washington, DC) • Defining the term “controlled substance”?

• Reviewing the scheduling process for both approval as well as postmarketing approval with both the DEA and FDA • Discussing the proper steps for companies who incorporate CBD’s into their products • What clinical trial lab work is necessary to demonstrate to the proper agencies?

• Exploring state regulations which exist when working with controlled substances • Implementing the manufacturing quotas which exist for these products 1:30

Clarifying the Clinical Trial Process for Drugs and Biologics microphone-alt Benjamin Zegarelli, Of Counsel, Mintz (New York, NY) • Overview of clinical trials and how they are used (including different phases) • Identifying the different parties involved (sponsors, investigators, CROs, etc.)

• Understanding human research protection (ICF, IRB) • Enforcement • Review of the “Right to Try” laws and their requirements during the clinical trials process 2:30

Afternoon Break

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters • Examining ANDA Standards for approval and the concepts of sameness and bioequivalence • Special considerations: local acting drugs, labeling carve outs and other nuances » Understanding the role of the Orange Book in the drug approval process • Market exclusivities and protection • Identifying the different types of exclusivities » Regulatory exclusivity (FDA)/ (data) exclusivity NCE (new chemical entity) » 5 years data exclusivity Indication (new indication or use) » 3 years marketing exclusivity NDF (new dosage formulation) ODE (orphan drug exclusivity) PED (pediatric exclusivity)

IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More 3:00

PART 1 Patents and Related IP Protections and Mechanisms microphone-alt Chad Landmon, Partner and Chair of Intellectual Property

and FDA Practice Groups, Axinn, Veltrop & Harkrider LLP (Hartford, CT)

Patent Protection for Drugs and Biologics • Summarizing the patenting process for drugs and biologics • Strategies for building patent protection for drugs and biologics • Applying for and achieving extension of patent term for time spent in the drug approval process » Patent Term Extension (“PTE”) » Patent Term Adjustment (“PTA”) • Reviewing the 271(e)(1) “safe harbor” provision • Distinguishing the patenting process for drugs from that of biologics • Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products

Biologics • Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA) • Understanding the rationale for safety and efficacy concerns surrounding second generation biologics • Exploring the concepts of “biosimilarity” or “interchangeability” • FDA rulemaking and guidance relative to biosimilars • Other points for consideration: substitution, naming, patents, and additional nuances • Examining biosimilar exclusivities • “Shall we dance” — weighing the pros and cons of participating in the patent dance • Deciding when to provide notice of commercial marketing

Trademarks • Overview of selecting a brand name for a proposed drug product • Roles of the USPTO and FDA in the drug naming process • Identifying the PTO and FDA clearances necessary for trade name/ trademark approval on your product • How does the branding process work for your product

4:45

Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process

3:45

PART 2 Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

microphone-alt Torrey Cope, Partner, Sidley Austin (Washington, DC) The labeling of the drug/biologic is the final stage of the approval process.

The label controls what you can do post-approval and as such it is the point of transition between the approval process and post-approval world.

microphone-alt Li Feng, Ph.D., Partner, Finnegan, Henderson, Farabow,

• • • •

Garrett & Dunner (Washington, DC)

Alexander J. Varond, Partner, Goodwin (San Francisco, CA) Jason G. Winchester, Partner, JONES DAY (Chicago, IL) Drugs

• • • •

• Overview of Hatch-Waxman and reforms » 30-month stay; patent extensions; ANDA filer exclusivity (180 day) • Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes » Reviewing fundamentals of applications

Labeling overview: key regulatory requirements, information, and contents Exploring the review process for labeling Incorporating clinical trial data on the label Appreciating the influence of final labeling on the scope of post-market activities Amending labeling post-ingmarket Using labeling as a defense in products liability litigation Exploring label carve outs Discussing the requirements for skinny and narrow labeling

5:30

Conference Adjourns to Day Two

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Main Conference Day 2 Thursday, March 23rd, 2023 (EST)

11:00

PART 2 Exploring the Subtleties and Safe Zones of Off-Label Communications microphone-alt Seth Mailhot, Partner, Husch Blackwell LLP (Washington, DC)

8:40

Co-Chairs’ Remarks and Recap of Day One microphone-alt Stacy Cline Amin, Partner, Morrison Foerster (Washington, DC), Former Chief Counsel, FDA

Kurt R. Karst, Partner, Hyman, Phelps & McNamara, P.C. (Washington, D.C.) 8:45

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process microphone-alt Cathy L. Burgess, P , artner, Alston & Bird LLP (Washington, DC) • Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization • Factoring cGMPs into the scope of the FDA’s authority • Exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs • Conducting laboratory investigations in relation to cGMPs • Understanding the influence of cGMPs in products liability litigation • Evaluating the costs and impact of enforcement actions

Advertising, Promotions, and Related First Amendment Concerns 9:45

PART 1 Drug and Biologics Advertising and Promotion 101 microphone-alt Bryant M. Godfrey, Partner and Co-Chair, Healthcare & Life Sciences and FDA Practice Groups, Foley Hoag LLP

• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics » 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA » Guidance documents • Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications) » What duties and responsibilities is DDMAC charged with? » What are its enforcement capabilities and jurisdiction?

• Identifying the role of the FTC in the advertising and promotion of drugs » SEC? • Advertising requirements for prescription v. nonprescription products • Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials » Overview of the promotional materials submission and review process • What constitutes a launch?

• What defines an advertisement? » What information must a drug advertisement include?

• Exploring the role of the label in advertising 10:30

Morning Break

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• Clarifying FDA’s current position on First Amendment and off-label promotion » The 21st Century Cures Act » FDAMA 114 • What to expect concerning proposed legislation, rules changes and Citizen Petitions • Cases and controversies: state AG actions and private tort claims 11:45

Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls • What is pharmacovigilance?

• How pharmacovigilance uses adverse event reports » Direct versus indirect reports » Causality assessments » Labeling changes » Pre-and post-market ADE reporting requirements » How regulatory agencies use ADE reports • Exploring protocols for Risk Evaluation and Minimization Strategies (REMS) • Understanding the role of risk evaluation in the approval process • Identifying risk minimization tools • Enforcing ADE reporting and REMS requirements • Examining the relevance to product liability risks, including innovator and co-promoter liability risks • What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)? » Guidance versus regulation » Voluntary recalls versus mandatory recalls » Market withdrawals and stock recoveries • Interaction between recalls and corrective and preventive action 12:45

Understanding the Scope of FDA Enforcement Authority and Actions microphone-alt Jennifer L. Bragg, Partner, Skadden LLP (Washington, DC) • Enforcement overview—identifying the players and their positions » Investigations, enforcement, litigation, and defenses • Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions • Exploring FDA compliance and enforcement mechanisms » Inspections For cause inspections vs. routine inspections Communication with the FDA during inspections » EIRs » Form FDA 483 observations » Untitled and Warning Letters Related to inspections Resulting from non-inspection data or information • Examining enforcement actions related to digital advertising and social media 1:30

Main Conference Ends

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Post-Conference Workshop Thursday, March 23rd, 2023 (EST)

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Post-Conference Workshop C

Clock

2:30–5:30 PM (3:30–4:00 PM Break)

Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

This workshop will build upon the content covered during the main conference on the regulatory and IP interplay in the Hatch-Waxman and BPCIA schematics. Our workshop leaders will in a step by-step manner: • Deconstruct complex exclusivity disputes • Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity • Explore bioequivalency conundrums Relevant court decisions will also be analyzed, and their practical and future effects discussed. Workshop attendees will have the opportunity to understand how the exclusivity “rules of the road” are applied in a real-world case.

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Stacy Cline Amin Partner Morrison Foerster (Washington, DC) Former Chief Counsel, FDA

Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

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